Standard blister-packs could serve as alternatives to colour coded unit dosed blister-packs in management of uncomplicat
Effectiveness and treatment adherence to artemether-lumefantrine colour coded unit dosed blister-packs versus standard blister-packs in the treatment of uncomplicated malaria in Ugandan children: a randomised controlled equivalence trial Joaniter I. Nankabirwa1,2, Samuel Gonahasa1, Bonnie Wandera2, Grace Nakanwagi1, Myers Lugemwa3, Mark Montague4, Sylvia Meek4, James K. Tibenderana1 1Malaria Consortium, Kampala, Uganda; 2Makerere University, Kampala, Uganda; 3Ministry of Health, Uganda; 4Malaria Consortium, London, UK
Key messages ͻ Risk of treatment failure (parasitological and clinical failure) and treatment adherence was not different between children who receive colour coded unit dosed blister-packs to those who receive standard packs. ͻ Standard blister-packs could serve as alternatives to colour coded unit dosed blister-packs in management of uncomplicated malaria without compromising effectiveness and adherence in Uganda.
Introduction Pre-packing drugs for treatment of uncomplicated malaria into colour coded unit doses has been shown to improve adherence and therefore effectiveness of treatment. However, it restricts access to those within the specific age or weight category and since each unit dosed blister-pack is a separate commodity, this creates challenges regarding procurement and administration. In addition, stock outs of unit dosed blister-packs may lead to either use of non-recommended therapies or the combination of smaller dose packs to make larger doses and cutting from larger dose packs to make smaller doses, resulting in over or under-dosing. This study investigated whether effectiveness and treatment adherence to standard blister-packs would be equivalent to unit dosed blister-packs.
Lumartem colour coded blue for children aged 3-8 years
Lumartem standard blister-pack
Methods An open-label individually randomised trial was conducted in 846 children aged six to 59 months and living in a high malaria transmission setting in Uganda. Children were randomised to receive colour coded unit dosed blister-packs or standard blister-packs, and followed up for 28 days. The primary outcome was treatment adherence. Secondary outcomes included risk of treatment failure, cure rates, change in mean haemoglobin, gametocytemia, and adherence.
Results Table 1: Baseline characteristics of the study participants by study group Colour coded unit dosed packs
Standard blister packs
Number of children Mean age (SD, months) Sex (Female, n %) Mean weight (SD, kg) Mean Hb (SD, g/dl) Mean parasite density (SD) P. Falciparum (n, %) P. Ovale P. Vivax Gametocyte present (n, %)
366 24.2 (16.2) 198 (54.1) 10.7 (3.2) 8.9 (1.7) 14,647 366 (100) 0 0 42 (11.5)
480 25.2 (16.1) 249 (51.9) 10.7 (3.0) 9.1 (1.7) 12,830 478 (99.6) 1 1 61 (12.7)
0.20
7
14 Duration in days
Unit dose colour coded
Colour coded unit Standard dosed packs blister-packs n/N (%) n/N (%)
P-value
Used labels as reminders for adherence
1/257 (0.3)
0.532
Reported missing some pills
11/346 (3.2)
14/458 (3.1)
0.935
Did not follow dosing schedules
26/357 (7.3)
30/475 (6.3)
0.568
Gave medicine without food
96/357 (26.9)
134/475 (28.2)
0.678
Still had tablets in the pack
66/358 (18.4)
89/472 (18.9)
0.855
28
21
Standard packs
Figure 2: Overall risk of adequate outcome, clinical failure and parasitological failure by study group 50 45 40 35 % risk
3/472 (0.6)
0.10 0
Table 2: Adherence by treatment group Outcome
p=0.896
0.00
cummulative risk
0.30
Variable
Figure 1: Cumulative risk of clinical failure over the 28 days of follow up unadjusted by genotyping
30 25 20 15 10 5
For more information: Dr Joaniter Nankabirwa,
[email protected] Malaria Consortium Uganda Plot 25, Upper Naguru East Road, Naguru, Kampala, Uganda www.malariaconsortium.org
0 Cure rates
Clinical failure Colour coded packs
Parasitological failure
Standard packs
Acknowledgements This study has been funded by UK aid from the UK government. However, the views expressed do not necessarily reflect the UK government’s official policies. The authors thank all organisations and individuals who participated in and supported this project .
